Stability & Regulatory Coordinator

3 days ago

Barrie, Canada CSR Cosmetic Solutions Full time

**GENERAL DESCRIPTION**

The Stability Coordinator is responsible for the HK Kolmar Canada stability program. The stability program includes but is not limited to maintaining all internal stability testing requirements, environmental chamber review and preventative maintenance scheduling, Research and Development stability support and finished product stability testing. This position is also responsible for supporting regulatory aspects associated with HK Kolmar Canada, where applicable.

**DUTIES/RESPONSIBILITIES**
- Responsible for the coordination of the Stability program at HK Kolmar Canada. Ensure all stability samples are tracked and organized to allow for samples to be extracted from the environmental chambers and tested at the appropriate intervals.
- Analyzes samples through visual review (appearance, odour, colour) and physical testing parameters (pH, viscosity, specific gravity) where required and record the data accordingly.
- Maintains organized lab notebooks, stability study binders, electronic documentation and stability sample retains.
- Coordinates yearly drug stability testing on new and existing products. Develops stability protocols and reviews protocols with customer’s quality and regulatory personnel to ensure compliance to standards.
- Provide stability samples and reports to customers quality and regulatory bodies as required upon review by the Stability and Regulatory Supervisor. Support investigations for out of specification results found during stability testing, working with both HK Kolmar Canada team and customers to provide root cause and corrective actions.
- Liaises with the Research and Development Chemist(s) and/or Manager for stability sample collection and documentation. Prepares documentation for all testing requirements, records data, and presents results to the R&D Chemist(s) and/or Manager on a routine basis. Highlights any out of specification results immediately to the Stability and Regulatory Supervisor and responsible R&D Chemist(s) and/or Manager.
- Completes compatibility protocols and studies as required, reviewing specifications to confirm acceptability of the packaging. Reports information to the customer upon review by the Stability and Regulatory Supervisor.
- Coordinates with the Quality Control Line Inspectors at HK Kolmar Canada to ensure proper finished good stability samples are collected to be placed in the stability program as outlined in the protocols.
- Coordinates with the Analytical and Microbial Labs at HK Kolmar Canada where required, to ensure analysis of stability samples is carried out at appropriate time intervals. Ensures out of specification results are reviewed and reported appropriately.
- Work with external laboratories to coordinate sample storage and testing as required.
- Coordinates with the HK Kolmar Canada Sales Team with stability updates and study progression to ensure proper information may be provided to customers.
- Maintains all equipment related to the stability process including daily and monthly preventative maintenance of the environmental chambers. Support yearly preventative maintenance and calibration activities. Daily calibration and review of testing equipment also required. Responsible for reporting any equipment failures or issues with the environmental chambers to the Stability and Regulatory Supervisor and working towards resolution.
- Supports in the gathering of raw material regulatory documentation as required. Helps to maintain and prepare regulatory documents for HK Kolmar Canada and customers.
- Works with the R&D lab interface (Coptis) to support regulatory and stability requirements.
- Complies with Good Manufacturing Practices, Standard Operating Procedures and Safety Standards, following proper policies and procedures.

**QUALIFICATIONS**

**Education**:

- Knowledge of Chemistry/Cosmetic Chemistry an asset
- Knowledge in Quality Control Principles an asset.

**Experience**:

- 1 year in a similar position preferred

Skills/Knowledge:

- Strong Organization Skills
- Strong interpersonal skills
- Excellent oral and written communication skills
- Understanding of current Industry, Governmental and Regulatory standards
- Ability to build and maintain positive internal and external relationships with all stake holders
- In-depth understanding of Customer requirements balanced with HK Kolmar Canada capabilities
- Computer competency required
- Knowledge of industry laboratory software (COPTIS) preferred
- **Access to a car and valid driver’s licence required.**
- If you are contacted for an interview and require any accommodation, please notify us in advance of your requirements_

**Benefits**:

- Company events
- Company pension
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- Vision care

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday

Supplemental pay types:

- Overtime pay

Ability to commute/relocate:

- BARRIE, ON: reliably co

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